Christine Kattappuram, Veeva MedTech07.19.22
Postmarket surveillance (PMS) is critical to ensure medical devices continue to be safe and effective for patient use. Yet, generating and managing surveillance plans, incident reports, CAPA documents, patient feedback, and other documentation required to remain compliant can burden medtech companies. The complexity in PMS is revealing significant challenges as a top 10 medtech was recently discovered to have approximately 200,000 uninvestigated complaint records over 10 years, leading to an extensive and costly recall.
The recent growth in publicized software-related Class I and Class II global recalls1 are increasing PMS workloads and making it harder to manage across products. Medtech organizations need a better, more efficient way to initiate, triage, and investigate product complaints because ignoring issues only magnifies problems.
The area is ripe for change, and more companies are looking to transform complaint handling and reporting, even as PMS remains one of the most challenging and expensive cost centers.2 By considering how current business processes can be enhanced and leveraging new technologies, medtech companies can start their journey to advance PMS and enable a more proactive approach.
To drive a successful PMS transformation, medtech companies should begin with a review of their existing business processes. This effort will help identify activities that are not value-add and opportunities to streamline operations. Because the industry has primarily used disconnected and highly customized solutions to manage PMS, it is critical to evaluate both business systems and processes to determine how they fit into PMS and establish a long-term strategy.
A quality management system (QMS) that enables connectivity across teams and stakeholders will make sharing data and content easier and allow users to gain a holistic, real-time view of complaints, adverse events, and related quality events. Using a modern QMS can also ensure a more proactive approach, helping identify repeat complaints and information needed for adverse event reports (AERs). Artificial intelligence (AI) and machine learning in the QMS can help automate manual processes and identify trends that previously went unnoticed in manual reviews.4
Taking a pilot approach lowers risks and quickly addresses the areas with the greatest need, like a site or business unit on a paper or legacy system. The feedback from these initial deployments will help refine the process and system design in smaller, more agile increments to ensure user adoption. As usage expands, the team leading this effort can create a center of excellence to drive long-term improvements.
Another way to start small and scale is by beginning an implementation with processes tangential to PMS, such as CAPA, audit, and supplier quality. This brings together synergistic processes with complaints and PMS, ensuring end-users gain more value from the system and delivering a greater return on investment. It can also help identify challenges and drive changes that meet key requirements before a broader rollout across PMS. Careful planning and a grounded thought process upfront will deliver project efficiency and cost savings during implementation.
A top 10 medical device manufacturer, for example, used its global AER process for identifying opportunities to improve operations. They required that each complaint file had an associated AER record where the reportability decision was completed. This was causing a high volume of duplicate records, making it challenging to identify the severity of adverse events and putting the company at risk of not meeting the required reporting timelines.
The exercise helped the company simplify the escalation process for the most critical complaint records (those indicating a severe injury or death). They could also add flags to each critical AER for special evaluation by a clinical representative while ensuring all other records continue to be reviewed as part of a batch process. These changes resulted in approximately a 75% reduction in time creating unnecessary AER records since the reportability decision is now captured and approved in the complaint record.
PMS leaders are ready to enhance efficiency through revamped processes and technology. Along with a holistic, connected QMS, these changes can help ensure proactive action, such as early notification and management of related supplier quality issues.
In the recall at the top 10 medtech, suppliers were unaware of PMS issues identified by the organization, causing a domino effect of problems that could have been avoided. Not having a closed-loop QMS to ensure communication with suppliers leaves organizations open to additional risk. Even minor improvements in how medtech firms manage PMS can benefit the organization, the industry, providers, and most importantly, patients.
References
Christine Kattappuram is senior director of quality strategy at Veeva MedTech. She has more than 15 years of experience in healthcare and medical devices. Prior to Veeva, Christine worked at Slalom Consulting and PwC helping companies manage and implement operations and growth strategies. She holds a bachelor of science and masters of science in industrial and systems engineering from the University of Wisconsin-Madison. She can be reached at christine.kattappuram@veeva.com.
The recent growth in publicized software-related Class I and Class II global recalls1 are increasing PMS workloads and making it harder to manage across products. Medtech organizations need a better, more efficient way to initiate, triage, and investigate product complaints because ignoring issues only magnifies problems.
The area is ripe for change, and more companies are looking to transform complaint handling and reporting, even as PMS remains one of the most challenging and expensive cost centers.2 By considering how current business processes can be enhanced and leveraging new technologies, medtech companies can start their journey to advance PMS and enable a more proactive approach.
Driving PMS Process Improvements
Organizations often create unnecessarily complex processes to serve as a “quick fix” in response to findings during an audit. For example, some fall into the trap of trying to close as many of the FDA Form 483 issues as possible before submitting a response to the FDA.3 This solves the urgent problem, but quick fixes usually result in overly customized systems and burdensome processes that can cause delays in addressing critical quality concerns.To drive a successful PMS transformation, medtech companies should begin with a review of their existing business processes. This effort will help identify activities that are not value-add and opportunities to streamline operations. Because the industry has primarily used disconnected and highly customized solutions to manage PMS, it is critical to evaluate both business systems and processes to determine how they fit into PMS and establish a long-term strategy.
Evaluating the Benefits of Connected Systems
Medtech companies commonly face challenges attempting to make meaningful improvements to legacy complaints systems or point solutions. Some have chosen a band-aid strategy, updating existing systems to drive process changes that meet audit requirements. The outcome is a system that cannot scale with the business, adds a heavy burden on IT staff, and isn’t user-friendly. Consider bringing in a new solution for true quality transformation, especially if PMS teams lack visibility into data and key trends.A quality management system (QMS) that enables connectivity across teams and stakeholders will make sharing data and content easier and allow users to gain a holistic, real-time view of complaints, adverse events, and related quality events. Using a modern QMS can also ensure a more proactive approach, helping identify repeat complaints and information needed for adverse event reports (AERs). Artificial intelligence (AI) and machine learning in the QMS can help automate manual processes and identify trends that previously went unnoticed in manual reviews.4
Implementing a Pilot for Long-term Success
The harmonization of 21 CFR Part 820 with ISO 13485 puts additional focus on risk management in medtech. This new change in regulations adds greater emphasis on reducing implementation risk, so establishing essential practices for quality and IT teams can help mitigate issues early on. Start small or take a crawl, walk, run approach for more flexibility and control. One common technique is to conduct a pilot that tests the feasibility of the proposed process change or new technology.Taking a pilot approach lowers risks and quickly addresses the areas with the greatest need, like a site or business unit on a paper or legacy system. The feedback from these initial deployments will help refine the process and system design in smaller, more agile increments to ensure user adoption. As usage expands, the team leading this effort can create a center of excellence to drive long-term improvements.
Another way to start small and scale is by beginning an implementation with processes tangential to PMS, such as CAPA, audit, and supplier quality. This brings together synergistic processes with complaints and PMS, ensuring end-users gain more value from the system and delivering a greater return on investment. It can also help identify challenges and drive changes that meet key requirements before a broader rollout across PMS. Careful planning and a grounded thought process upfront will deliver project efficiency and cost savings during implementation.
Modernizing PMS in the Real World
Change in PMS is possible by mapping processes, identifying areas of improvement, evaluating technology, and establishing an implementation strategy that can scale. With the shift to digital, many organizations are already making positive strides to increase efficiency in PMS.A top 10 medical device manufacturer, for example, used its global AER process for identifying opportunities to improve operations. They required that each complaint file had an associated AER record where the reportability decision was completed. This was causing a high volume of duplicate records, making it challenging to identify the severity of adverse events and putting the company at risk of not meeting the required reporting timelines.
The exercise helped the company simplify the escalation process for the most critical complaint records (those indicating a severe injury or death). They could also add flags to each critical AER for special evaluation by a clinical representative while ensuring all other records continue to be reviewed as part of a batch process. These changes resulted in approximately a 75% reduction in time creating unnecessary AER records since the reportability decision is now captured and approved in the complaint record.
PMS leaders are ready to enhance efficiency through revamped processes and technology. Along with a holistic, connected QMS, these changes can help ensure proactive action, such as early notification and management of related supplier quality issues.
In the recall at the top 10 medtech, suppliers were unaware of PMS issues identified by the organization, causing a domino effect of problems that could have been avoided. Not having a closed-loop QMS to ensure communication with suppliers leaves organizations open to additional risk. Even minor improvements in how medtech firms manage PMS can benefit the organization, the industry, providers, and most importantly, patients.
References
Christine Kattappuram is senior director of quality strategy at Veeva MedTech. She has more than 15 years of experience in healthcare and medical devices. Prior to Veeva, Christine worked at Slalom Consulting and PwC helping companies manage and implement operations and growth strategies. She holds a bachelor of science and masters of science in industrial and systems engineering from the University of Wisconsin-Madison. She can be reached at christine.kattappuram@veeva.com.
